| CTRI Number |
CTRI/2025/10/095588 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Compare Hs-CRP levels in periodontitis patients with and without cardiovascular disease |
|
Scientific Title of Study
|
COMPARATIVE ANALYSIS OF HIGH-SENSITIVE
C-REACTIVE PROTEIN LEVELS IN SALIVA OF PATIENTS WITH CHRONIC PERIODONTITIS WITH AND WITHOUT CARDIOVASCULAR DISEASE. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Kabra |
| Designation |
post graduate student |
| Affiliation |
AB Shetty institute of medical sciences |
| Address |
4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
08329104470 |
| Fax |
|
| Email |
shraddhakabra144@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR.AMITHA RAMESH |
| Designation |
head of department |
| Affiliation |
|
| Address |
4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9845407984 |
| Fax |
|
| Email |
dramitharamesh@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Shraddha Kabra |
| Designation |
post graduate student |
| Affiliation |
AB Shetty institute of medical sciences |
| Address |
4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
08329104470 |
| Fax |
|
| Email |
shraddhakabra144@gmail.com |
|
|
Source of Monetary or Material Support
|
| ELISA Kit from Krishgen biosystems private limited, Mumbai,Maharashtra,India 400018. phone no: 9967876632 |
|
|
Primary Sponsor
|
| Name |
Shraddha kabra |
| Address |
4th floor, department of periodontology ,AB Shetty memorial institute of medical sciences, Deralakatte , Mangalore, Karnataka,India, 575018 |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shraddha Kabra |
ABSMIDS,NITTE University, Mangalore, Karnataka |
4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka Dakshina Kannada KARNATAKA |
08329104470
shraddhakabra144@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
for Group 1, Subjects included in the study will be patients with chronic periodontitis without cardiovascular disease having normal triglycerides and cholesterol levels
for Group 2, Subjects included in the study will be chronic periodontitis patients with coronary artery disease who are certified by the cardiology department of nearby hospitals
All patients having at least 10 natural teeth without any type of restoration except third molars
Subjects with Gingival Index according to Loe and Silness of moderate gingivitis will be considered for both groups
Subjects with clinical attachment loss greater 3mm will be considered in both the groups that is according to CDC Classification
|
|
| ExclusionCriteria |
| Details |
For group 1, subjects with any systemic diseases and on medications.
For group 2, subjects with any systemic diseases other than coronary artery disease.
Subjects on any anti–anxiety drugs in the last 6 months.
Subjects having habits detrimental to oral health, for example smoking, consuming alcohol, betel nut chewing or using any other form of tobacco.
Patients who had undergone any periodontal treatment in the previous six months, using any orthodontic appliances or dental prosthesis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salivary Hs-CRP levels |
baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relation with periodontitis and cardiovascular disease |
baseline |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic periodontitis is a progressive inflammatory disease that damages the supporting structures of teeth and, if untreated, can lead to tooth mobility and loss. Beyond its oral effects, it has systemic implications, particularly in cardiovascular health. Coronary artery disease, an inflammatory atherosclerotic condition, may be influenced by the systemic inflammation associated with periodontitis. Saliva has gained attention as a diagnostic fluid due to its easy and non-invasive collection. It has been explored for detecting biomarkers of systemic conditions like cardiovascular disease, diabetes, and rheumatoid arthritis, as well as for monitoring oral diseases such as periodontal disease and oral cancer. However, salivary content can vary depending on factors like age, smoking, and systemic health. High-sensitivity C-reactive protein (hs-CRP) is a widely recognized marker of systemic inflammation and cardiovascular risk. Elevated hs-CRP levels have been observed in both cardiovascular disease and periodontitis, suggesting a link between these two conditions. While traditionally measured in serum, salivary hs-CRP has emerged as a convenient, cost-effective, and non-invasive alternative. There is limited research comparing salivary hs-CRP levels in patients with chronic periodontitis with and without cardiovascular disease. This study aims to evaluate whether salivary hs-CRP can serve as a biomarker for identifying individuals at higher cardiovascular risk, explore the correlation between periodontitis severity and hs-CRP levels, and investigate the shared inflammatory pathways. Ultimately, this research seeks to establish salivary hs-CRP as a useful tool for early detection and integrated management of systemic risks in patients with chronic periodontitis. |